Abstract
BACKGROUND: Tackling poor mental health in university students is a priority in higher education. Although major depressive disorder and generalized anxiety disorder are highly prevalent among university students and predict impaired university and later life outcomes, most students do not receive evidence-based treatment. Internet-delivered cognitive-behavioural therapy (iCBT) is increasingly offered to UK university students in guided or unguided formats. Our aim is to compare the effects of guided versus unguided scalable iCBT for university students with elevated symptoms of depression and/or anxiety and to investigate the feasibility of creating individual treatment rules (ITR) to predict for whom which variant of iCBT is more effective as well as for whom neither is effective. METHODS: An online single-blind, two-arm parallel-group randomized controlled trial to examine symptoms of depression and anxiety across 3 months in university students aged over 16 who screen into the study with self-reported high levels of anxiety (GAD-7 > 9) and/or depression (PHQ-9 > 9). Eligible participants will be randomized to guided transdiagnostic iCBT supported by a psychological wellbeing practitioner or to the same transdiagnostic iCBT content as unguided self-help. In total, 720 participants with no current bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomization) and 3 months post-randomization. Primary endpoints and outcomes are self-reported depression and anxiety symptoms at 3-month follow-up, adjusting for baseline scores. Well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be monitored. We will use machine learning to estimate heterogeneity of treatment effects and develop an ITR to optimize the allocation of students to either unguided or guided iCBT. DISCUSSION: The trial aims to provide a better understanding of the relative benefits of guided and unguided iCBT for anxiety and depression in university students with considerable implications for treatment coverage and service planning and delivery. We will provide innovative information to optimize treatment assignment, guide university mental health treatment planning and support evidence-based and scalable interventions for the most common mental health problems in university students. TRIAL REGISTRATION: ISRCTN: 56784470, https://www.isrctn.com/ISRCTN56784470 . Registered on 27 October 2022.